Methods for delivering a prosthesis to a site in a body

ABSTRACT

An endoprosthesis cover may be attached to the distal end of a delivery device. The cover may be generally cylindrical in shape and may have a lumen through it. An endoprosthesis may then be covered as it is delivered to a treatment site.

RELATED APPLICATION DATA

This application is a continuation of application Ser. No. 10/001,538,filed Nov. 14, 2001, now U.S. Pat. No. 6,846,316, which is acontinuation of application Ser. No. 09/459,143, filed Dec. 10, 1999,now U.S. Pat. No. 6,331,184.

FIELD OF THE INVENTION

The present invention generally relates to devices implanted within thehuman body and further to coverings about those devices. Specifically,the present invention relates to a detachable system for covering animplantable devices as it is delivered into the human body. Thoseskilled in the art will recognize the benefits of applying the presentinvention to similar fields not discussed herein.

BACKGROUND OF THE INVENTION

A variety of devices are now commercially available for implantationthrough minimally invasive techniques. These devices include stents andstent-grafts used to maintain patent flow in blood vessels, theendo-biliary system or the urinary system. These stents and stent graftshave several different forms. Some are in the form of coiled wires whileothers are made from slotted tubes. Stents are also generallyself-expanding or balloon expandable. Typically, they are made frommetal and have a few important characteristics. These characteristicsinclude expanded hoop strength, expansion force, expanded and unexpandeddiameter, and the amount of foreshortening during expansion. Obviouslythe art of stent design is to work with these conflictingcharacteristics in such a way as to form the ideal stent. That stentwould require very little force to expand, start with a very smallunexpanded diameter and reliably expand to whatever diameter desired andthe stent would not foreshorten when expanded.

Another important characteristic of a stent or stent-graft is the amountof expanded stent material that comes into contact with the vessel.Having the surface of the stent in contact with the stent is importantbecause of in-stent restenosis. In-stent restenosis is a phenomenonwhere, for some reason, the vessel grows through the struts or betweenthe coils and thereby obstructs fluid flow in the vessel. Where thestent is in direct contact with the vessel, the vessel can not impingeon the fluid flow. There is, therefore, a need for a stent whichmaximizes all of the characteristics above and has as close to 100%vessel contact in the area that is stented as possible.

Another type of device may generally be characterized as aneurysm repairdevices. Depending upon where in the body the aneurysm is located, aruptured aneurysm may be fatal. Typically aneurysm repair devices areused to prevent the aneurysm from getting larger and ultimatelybursting. Exemplary types of aneurysm repair devices include those whichprotect the aneurysm from getting larger by shielding the aneurysm fromfluid pressure, covering the neck of an aneurysm, or filling theaneurysm with some sort of packing material. Similar to stents, aneurysmrepair devices have a variety of conflicting material characteristicswhich make them perform better, most notably surface contact or sealingcapability. In addition, present coil-shaped repair devices have apotential for the leading edge of the coil to corkscrew into the vesselwall. There is therefore a need for an aneurysm repair device that hasgood sealing characteristics and one which would be less likely tocorkscrew into the vessel wall.

U.S. Pat. No. 5,334,210 describes a prior art vascular occlusionassembly and is depicted in FIG. 1 of the current application. Theassembly comprises a foldable material occlusion bag which is filledwith a flexible filler. Because the material is not non-compliant, itmust be folded and must therefore disadvantageously increase the profileof the device. This bag may be positioned in a blood vessel and isintended to stop fluid from flowing through the vessel. There istherefore no lumen in the device.

Overall there is need for a prosthesis which has nearly complete vesselwall contact while maintaining a patent fluid channel. This prosthesisand its accompanying delivery system would be highly advantageous.

SUMMARY OF THE INVENTION

The present invention overcomes the deficiencies of the prior art byproviding a sheath attached to the distal end of a delivery device. Thesheath may be generally cylindrical in shape and have a lumentherethrough. The sheath may be expandable such that, as anendoprosthesis is delivered into the lumen of the sheath, the sheathwill take on the exterior configuration of the endoprosthesis. Theendoprosthesis is thereby covered while maintaining a patent fluidlumen. The sheath may further be detachable from the delivery device andmay have holes or slots to enhance blood porosity and to enhance itsdistensability. The endoprosthesis may include stents, coils, stentgrafts, aneurysm repair devices or any other endoprosthesis known in theart.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a prior art device.

FIG. 2 illustrates a first embodiment of the delivery system.

FIG. 3 depicts a partially deployed coil with the delivery system.

FIG. 4 depicts a fully deployed stent in a body lumen.

FIG. 5 illustrates a second endoprosthesis.

FIG. 6 illustrates a third endoprosthesis.

FIG. 7 depicts the third endoprosthesis partially deployed.

FIG. 8 illustrates the third endoprosthesis fully deployed in ananeurysm neck.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description should be read with reference to thedrawings in which like elements in different drawing are numberedidentically. The drawings, which are not necessarily to scale, depictselected embodiments and are not intended to limit the scope of theinvention.

Examples of constructions, materials, dimensions, and manufacturingprocesses are provided for selected elements. All other elements employthat which is known to those skilled in the field of the invention.Those skilled in the art will recognize that many of the examplesprovided have suitable alternatives that may also be used.

Turning now to FIG. 1. Delivery system 15 includes tube 10. Tube 10 maybe a micro-catheter, guide catheter, hypotube or any other type of tubecommonly known in the art. Depending on the application, the innerdiameter or tube 10 may be 0.008-0.39 inches. Tube 10 may be formed of apolymer or a combination of polymers, metal, a metal polymer composite,a combination of polymers and metallic braid (not shown). Surrounding adistal portion of tube 10 is sheath 20. Sheath 20 may preferably be madeof an elastomer or other highly compliant polymer. Such polymers mayinclude latex, styrenic block copolymers such as SBS and SEBS made byShell under trade name of Kraton, polyether-ester block copolymers(COPE) for co-polyesters made by DuPont under the trade name of Hytrel,thermoplastic polyamide elastomers (PEBA) made by Atochem under thetrade name of Pebax, and thermoplastic polyurethane elastomer (TPUR)made by Dow under the trade name Pellathane, or thermoplastic polyolefinelastomers (TPOs).

Sheath 20 may further include a proximal opening 25 and a distal opening27. In its non-distended configuration, sheath 20 may generally form acylinder. Sheath 20 may have a ridge (not shown) on its interior neardistal opening 27 which may be configured to better capture the distalend of a prosthesis. In an alternative embodiment, sheath 20 may haveslots or holes (not shown) which would enhance the porosity of sheath 20and provide better flexibility.

Sheath 20 may be frictionally fit about the distal end of tube 10. In apreferred embodiment, an adhesive bond 30 binds sheath 20 to tube 10.Sheath 20 may detach from tube 10 in a variety of ways. Where sheath 20is frictionally fit over tube 10, detachment may be achieved simply byovercoming the frictional forces between sheath 20 and tube 10, e.g.pushing a prosthesis out of the distal end of tube 10. Where sheath 20is attached to tube 10 by adhesive bond 30, the adhesive may beengineered to detach at any desired force. Adhesive bond 30 may beformed with any medically approved adhesive. In an alternativeembodiment, sheath 20 may have a circumferential perforation distal ofadhesive bond 30 and thereby provide sheath 20 with a tear awaydetachment mechanism.

Turning now to FIG. 3. Delivery system 15 is shown with a partiallydeployed self expanding coil 35. Coil 35 may be attached to pusher wire40. When pusher wire 40 is moved distally relative to tube 10, thedistal portion of coil 35 engages the distal portion of sheath 20.Sheath 20 then distends distally has coil 35 is advanced further out oftube 10. Once the entire coil 35 has been pushed out of tube 10, pusherwire 40 may be electrolytically detached. Methods of electrolytic detachare describe in U.S. Pat. No. 5,122,136 which is hereby incorporated byreference. It may further be appreciated that a variety of detachmechanisms are available to serve this function and furthermore thatpusher wire 40 does not need to be attached to coil 35.

FIG. 4 depicts delivery system 15 in use in the vasculature. In thisembodiment, a self-expanding stent 45 has been introduced into a bloodvessel. Pusher 40 has been advanced such that stent 45 was forced out oftube 10 and into contact with the interior of sheath 20. After sheath 20detached from tube 10, sheath 20 remains in place about stent 45 andprevents any incursion by the surrounding tissue into the lumen of stent45 and thereby maintains a patent fluid lumen for blood to flow through.Another embodiment is depicted in FIG. 5 where a tulip shaped coil 50 isplaced in a body lumen.

FIG. 6 illustrates yet another embodiment where wire 55 is advancedthrough tube 10. Wire 55 may be formed of any suitable medicallyapproved metal such as stainless steel or alloys of nickel such asNitinol. Wire 55 has a pre-curved shape and is only forced out of thatshape by placing wire 55 into tube 10. Care should be taken to choose amaterial for sheath 20 which will conform to the pre-curved shape ofwire 55 without deforming wire 55.

As can readily be appreciated from FIG. 7, as wire 55 emerges from tube10 it enters sheath 20 and resumes its pre-curved shape. In thisembodiment, wire 55 is pre-curved into a flat disc-like shape but couldbe any of a variety of shapes known in the art. As described above,further advancement of wire 55 eventually detaches sheath 20 from tube10 and thereby delivers pre-curved wire 55 into a desired location withsheath 20 surrounding wire 55. FIG. 8 depicts a particular use ofpre-curved wire 55. In this embodiment wire 55 forms into a disc-likeshape suitable for covering an aneurysm neck. Wire 55 may be deliveredwithout any other structure being placed into aneurysm 60.Alternatively, wire 55 may be delivered after particles or other embolicmaterials (not shown) have been deployed into aneurysm 60. In anotherembodiment wire 55 may be delivered into aneurysm 60 and particles maybe delivered through wire 55 thereby filling aneurysm 60 and capping itwith wire 55.

While the specification describes the preferred designs, materials,methods of manufacture and methods of use, those skilled in the art willappreciate the scope and spirit of the invention with reference to theappended claims.

1. A method for delivering a prosthesis to a site in a body, comprising:providing a delivery system comprising a tubular member having a sheathreleasably affixed to a distal end of the tubular member, said sheathhaving a distal opening and a lumen therethrough, said distal openingand said lumen of sufficient size to maintain patent blood flow throughthe lumen; advancing the tubular member through a vessel in a body toposition the tubular member distal end at a site in the body; advancinga prosthesis which is not within the sheath, through an opening in thetubular member distal end and into the sheath, the delivery of theprosthesis into the sheath causing the sheath to release from thetubular member, such that the sheath containing the prosthesis isdelivered to the site; and maintaining patent blood flow through thelumen and through the distal opening while said sheath is positioned atthe site in the body.
 2. The method of claim 1, wherein the site is ananeurysm neck.
 3. The method of claim 1, wherein the site is ananeurysm.
 4. The method of claim 1, wherein the sheath comprises aplurality of slots or holes.
 5. The method of claim 1, wherein thesheath is frictionally fit to the distal end of the tubular member. 6.The method of claim 1, wherein the sheath is affixed by an adhesive bondto the distal end of the tubular member.
 7. The method of claim 1,wherein the prosthesis expands as it is advanced out of the tubularmember opening and into the sheath.
 8. The method of claim 7, whereinthe sheath distends to conform to the expanded prosthesis.
 9. The methodof claim 1, the prosthesis comprising an occlusive coil that is advancedthrough the tubular member using a pusher wire, and wherein the coil iselectrolytically detached from the pusher wire once the coil is advancedout of the tubular member and into sheath.
 10. A method for delivering aprosthesis to a site in a body, comprising: providing a delivery systemcomprising a tubular member having a delivery lumen in communicationwith an opening in the tubular member, and a sheath having a proximalend releasably affixed to an exterior of the tubular member proximatethe opening, said sheath having a distal opening and a lumentherethrough, said distal opening and said lumen of sufficient size tomaintain patent blood flow through the lumen; advancing the tubularmember through a vessel in a body to position the opening proximate asite in the body; advancing a prosthesis which is not within the sheath,through the delivery lumen, out the opening, and into the sheath, thedelivery of the prosthesis into the sheath causing the sheath to releasefrom the tubular member, such that the sheath containing the prosthesisis delivered to the site; and maintaining patent blood flow through thelumen and through the distal opening while said sheath is positioned atthe site in the body.
 11. The method of claim 10, the prosthesisexpanding as it is advanced out of the tubular member opening and intothe sheath, wherein the sheath distends to conform to the expandedprosthesis.
 12. The method of claim 10, the prosthesis comprising apre-curved wire that forms a disc-like shape suitable for covering ananeurysm neck when delivered into the sheath.
 13. The method of claim10, wherein the site is an aneurysm neck.
 14. The method of claim 10,wherein the site is an aneurysm.
 15. The method of claim 10, wherein thesheath comprises a plurality of slots or holes.
 16. The method of claim10, wherein the sheath is frictionally fit to the distal end of thetubular member.
 17. The method of claim 10, wherein the sheath isaffixed by an adhesive bond to the distal end of the tubular member. 18.A method for delivering a prosthesis to a site in a body, comprising:providing a delivery system comprising a tubular member having adelivery lumen in communication with a distal opening in the tubularmember, and a sheath having a proximal end releasably affixed to anexterior of the tubular member around the distal opening, said sheathhaving a distal opening and a lumen therethrough, said distal openingand said lumen of sufficient size to maintain patent blood flow throughthe lumen; advancing the tubular member through a vessel in a body toposition the distal opening proximate a site in the body; advancing aprosthesis which is not within the sheath, through the delivery lumen,out the distal opening, and into the sheath, the prosthesis expanding asit is advanced out of the tubular member opening and into the sheath,the sheath conforming to the expanded prosthesis, the advancing of theprosthesis causing the sheath to release from the tubular member; andmaintaining patent blood flow through the lumen and through the distalopening while said sheath is positioned at the site in the body.
 19. Themethod of claim 18, further comprising detaching the sheath from thetubular member as the prosthesis is deployed.
 20. The method of claim18, wherein the site is an aneurysm.